エンフロン® II ミニ・クリーンパック™ 20 カプセルフィルター product photo Primary L

エンフロン® II ミニ・クリーンパック™ 20 カプセルフィルター

Small Scale, Gamma Compatible, Sterilizing Grade Air Filtration

For single-use installations, from upstream to final formulation and fill, Emflon II membrane air capsule filter is the go-to gas filter for safeguarding cell cultures and drug products from adventitious bacterial and viral contamination.

Mini Kleenpak 20 capsules with Emflon II membrane deliver gamma-compatible sterilizing grade air filtration for use on small-scale process gas and vent applications. With a comprehensive validation and quality package, Mini Kleenpak 20 capsules with Emflon II membrane are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

Features and Benefits

  • Highly retentive Emflon II membrane for sterility assurance
  • High flow rates associated with low differential pressure enable the use of small filters leading to a reduction of installation and operating costs
  • Gamma-irradiatable or autoclavable for maximum convenience
  • Integrity testable using the bubble point test

High Quality Standards

  • Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 organisms/cm2 of filter area
  • 100% integrity tested during manufacturing
  • Filters supplied with a pharmaceutical certificate of test
  • Comprehensive validation guide available
  • Manufactured under a Quality Management System certified to ISO 9001:2015

Biological Tests

  • Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121 °C

Effluent Quality Tests*

  • Meets cleanliness per USP particulates in injectables
  • Non-fiber-releasing per 21CFR 211.72 and 21CFR 210.3(b)(6)
  • Non-pyrogenic per USP bacterial endotoxins (< 0.25 EU/mL)

* Per lot samples on rinse-up flush aliquots



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概要

Small Scale, Gamma Compatible, Sterilizing Grade Air Filtration

For single-use installations, from upstream to final formulation and fill, Emflon II membrane air capsule filter is the go-to gas filter for safeguarding cell cultures and drug products from adventitious bacterial and viral contamination.

Mini Kleenpak 20 capsules with Emflon II membrane deliver gamma-compatible sterilizing grade air filtration for use on small-scale process gas and vent applications. With a comprehensive validation and quality package, Mini Kleenpak 20 capsules with Emflon II membrane are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

Features and Benefits

  • Highly retentive Emflon II membrane for sterility assurance
  • High flow rates associated with low differential pressure enable the use of small filters leading to a reduction of installation and operating costs
  • Gamma-irradiatable or autoclavable for maximum convenience
  • Integrity testable using the bubble point test

High Quality Standards

  • Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 organisms/cm2 of filter area
  • 100% integrity tested during manufacturing
  • Filters supplied with a pharmaceutical certificate of test
  • Comprehensive validation guide available
  • Manufactured under a Quality Management System certified to ISO 9001:2015

Biological Tests

  • Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121 °C

Effluent Quality Tests*

  • Meets cleanliness per USP particulates in injectables
  • Non-fiber-releasing per 21CFR 211.72 and 21CFR 210.3(b)(6)
  • Non-pyrogenic per USP bacterial endotoxins (< 0.25 EU/mL)

* Per lot samples on rinse-up flush aliquots

仕様

Materials of Construction

 
 Membrane PVDF
 Capsule Polypropylene
 

 

Nominal Dimensions

 
Housing Diameter 68 mm (2.7 in.)
Inlet/Outlet Hosebarb Length 83 mm (3.3 in.)
Nominal effective filtration area 20 cm2 (0.022 ft2)
 

 

Operating Conditions1

 
 Maximum Operating Temperature and Pressure  2.0 bard (29 psid) at 20 °C 
 

1 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization2

 
Gamma-irradiation  Maximum 50 kGy
Autoclave at 131 °C, 3 x 60 minute cycles
 

Warning: Pre-sterilized Mini Kleenpak 20 capsules (as supplied on some single-use systems) should not be re-sterilized. Contact Pall in regards to re-sterilizing gamma-irradiated Mini Kleenpak 20 capsules. The capsules must not be sterilized in-situ by passing steam under pressure. Do not autoclave after use if heat labile chemical contaminants are present on the filter.

2 The figures are maximum allowable figures determined by testing under controlled laboratory conditions to the length of time indicated. Actual operating conditions may affect the filter’s long term response to sterilization. Filters should be qualified for each process application.



Typical Flow Rates3

Figure 1
Vent conditions for Mini Kleenpak 20 capsules



3 For gases other than air or nitrogen, contact your local Pall representative

製品カテゴリー

カプセルフィルター

型式

 
Part Number Description Quantity Per Box
KM5V002P2G Mini Kleenpak 20 filter capsule with 0.2 μm Emflon II membrane and ¼ – ½ in. (6 – 13 mm) hosebarb connections, supplied non-sterile, gamma-irradiatable /autoclavable 3
KM5V002P2G100 100
 

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